NCT03001817

Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function

A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double-Blind, 12-Week Study With a 40-Week, Active-Controlled, Double-Blind Extension to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting Triglyceride Levels ≥500 mg/dL and <2000 mg/dL and Normal Renal Function

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 551 (actual)
• Sponsor: Kowa Research Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients with fasting high triglyceride levels ≥500 mg/dL and \<2000 mg/dL and normal renal function.

Conditions

• Severe Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	K-877
DRUG	Fenofibrate
DRUG	Placebo (for K-877)
DRUG	Placebo (for Fenofibrate)

Timeline

• Start date: 2016-11-28
• Primary completion: 2019-06-24
• Completion: 2019-06-24
• First posted: 2016-12-23
• Last updated: 2022-11-30
• Results posted: 2022-11-30

Locations

220 sites across 9 countries: United States, Belarus, Bulgaria, Czechia, Georgia, Hungary, Poland, Russia, Ukraine

Regulatory

• FDA-regulated drug study